With each of our innovator stories, we get a chance to meet the people behind EU-funded ideas, which have the potential to change our future for the better.
This time, we met Angela Liedler MD, CEO and main shareholder of Precisis, a German company specialised in the development of innovative medical devices. Its greatest success has been achieving CE mark for the minimally invasive brain pacemaker EASEE® for the treatment of focal epilepsies in adults. Dr. Angela Liedler participated in Dealflow.eu’s E-Pitching event dedicated to Female-Led Innovations. Following being considered the best pitch, the Precisis’ CEO was invited to participate as a speaker in the Women Leadership Session, also organised by Dealflow.eu.
Precisis was supported by the EU with more than €2.5M in grants so far via different R&I projects, such as BFORE.
Tell us more about yourself and your work?
In 2011, I took over as CEO and main shareholder of Precisis and, through EASEE®, I started a visionary project to revolutionise epilepsy treatment. Precisis aims to improve the lives of patients suffering from functional brain disorders, by providing novel neurostimulation technologies.
Our team currently consists of 24 members, being 41% women. We all share an enterprising spirit and the common goal of bringing next-generation neuromodulation solutions to the patient bedside. The personalities and backgrounds are quite diverse: there are physicists, physicians, psychologists, and mathematicians. We keep each other on our toes and like challenging one another to think outside one’s own box to achieve the best possible outcome for our patients.
What problem is your product solving and what makes its solution unique?
Epilepsy is one of the most common neurological disorders. Estimates suggest that around 50 million people worldwide are suffering from it (WHO). Many patients with epilepsy have a clear need: they are looking for the ultimate way out of a medical predicament. In fact, oral medication is not able to help one in three epilepsy patients. These are patients who continue to have epileptic seizures even while being treated with strong medication or they are severely troubled by pharmacological side effects. They are not able not take part in social or professional life the way most would want to. Some require round-the-clock care and need to fall-proof their house. All this takes a huge toll on the mental health of the patients and their families.
Treatment options for those so-called pharmacorefractory patients today include cutting out the part of the brain responsible for the seizures, a crude and scary procedure, or highly invasive and/or ineffective neurostimulation techniques.
In contrast to other devices in the treatment of epilepsy, EASEE® just gets slipped underneath the skin right above the individual epileptic focus. That way, EASEE® is the only available device in Europe where the seizure onset zone is being directly stimulated. The design is based on the Laplace electrode. Because of this setup, a therapeutically meaningful and very focused electrical field can reach the diseased brain area. The minimal invasive implantation procedure only requires two cuts in the skin, one on the head for the placement of the electrode, and one in the chest area for the IPG. No sensitive tissue like nerves or the brain are being touched.
Apart from the minimal invasive implantation, another uniqueness of EASEE® is the combination of two proven clinically effective stimulation paradigms. One, high-frequency alternating current, is delivered in short bursts throughout the day and is meant to interfere with upcoming seizures. The other, direct current-like stimulation is applied once a day for 20 minutes and will calm the brain in the long-term. The stimulation intensity for both is set below sensory threshold, so cannot be felt by the patient.
How did you start your journey, and where are you now on the road to achieving your ambition?
While I was witnessing the implantation of a deep brain stimulation system (DBS) for the treatment of epilepsy, a procedure where electrodes are inserted deep into the brain, far from the seizure onset zone, the question arose: why it was not possible to “simply” suppress seizures at their origin with electrical impulses? Before 2015, however, no one had come up with a minimally invasive, low-risk, yet precise, bioelectronic solution for epilepsy – the start of EASEE®.
After several prototypes, bench-tests, pre-clinical and tremendous clinical studies, EASEE® received CE-mark for the treatment of pharmaco-refractory focal epilepsies in adults in September 2022. It has now entered the commercial phase and is available for epilepsy patients.
What’s the biggest impact EU-funding has had on your journey so far, and can you specify an outcome?
Precisis has won €2.4M from the EIC Accelerator in December 2022 as one of 78 out of over 1,000 applicants from the October deadline. The money will be applied to entering European markets. Precisis is well equipped to handle market access in the DACH-region on their own, but to set up sales force, marketing and secure reimbursement in the various European countries, the funds from the Accelerator program will be used.
Have you already tested your product with clients? What was it like?
EASEE® has gone through two clinical studies with outstanding results. Of the severely ill study participants, 84% were able to benefit from stimulation provided by EASEE®, 53% reduced their seizure frequency by ≥50% (so-called responders), and 17% became completely seizure free after six months of stimulation. No antiepileptic drug was able to help these patients.
The results have recently been published in JAMA Neurology (see full publication here) and present a potential game changer in the treatment of pharmacorefractory epilepsy.
What is your company’s greatest achievement to date?
Our biggest accomplishment was achieving CE-mark for a class III active implant as such a small company in just seven years under the new MDR regulation.
A class III medical device requires the highest quality of data and documentation to receive CE-mark and be commercially available. Under the new MDR-regulation, this means even more documentation work for the manufacturer. Even the big players in the medtech business are struggling with it. We are extremely proud to have been able to take a visionary idea to the market.
How do you see your company making a difference in the future?
EASEE® has the potential to be a game changer in the treatment of epilepsy and other neurofunctional disorders. It has shown great success in treating adult epilepsy patients and soon a clinical study for children and teenagers will start. This demographic is suffering most from seizures’ long-term effects and at the same time is often overlooked as a patient group in need.
EASEE® will also be applied for other disorders. It can make a huge difference for patients with major depression, a very common and debilitating mental illness.
It does not only help the individual patient, but also their family and friends, as the patients will require less care and have a more burden-free life. It also lowers the anxiety experienced by care-givers.
Why is participation in Dealflow.eu’s e-pitching event and receiving their coaching important to you?
The e-pitching event was helpful to get the message out about EASEE® and get in touch with potential investors. Precisis is currently starting a new investment round, so having the exposure was a good experience.
Receiving your coaching on the slide deck and presentation was very useful, as an objective voice from outside the team can offer valuable insights for a successful pitch.
How would you define success and what keeps you going in the pursuit of it?
Success can mean multiple things. For anyone working in the medical field, success is being able to help and support severely ill patients and reduce their burden. This is also what keeps us going, Precisis is offering meaningful jobs and the feeling of being able to change patients’ lives for the better.
On the other hand, success is something entrepreneurial. After having invested time and money into a project and company, it is rewarding to see this investment paying off.
Article published by EurA AG.
About Innovator Spotlight Stories
The aim of innovator stories is to highlight and share with investors and relevant stakeholders in the industry, insights, and unique stories from some of the most innovative EU-funded project that Dealflow.eu is proud to support.
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Supported by the European Commission, Dealflow.eu discovers and supports the most promising EU-funded innovators and connects them with relevant investors and corporates. The initiative was launched to help groundbreaking innovations secure the funding needed for their future commercialisation by offering them tailored support and matchmaking services.
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Disclaimer: Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Directorate-General for Communications Networks, Content and Technology. Neither the European Union nor the granting authority can be held responsible for them.
